Sample Receipt & Report Dispatch Unit
Sample Receipt & Report Dispatch Unit
  1. National Institute of Biologicals has been established as an autonomous organization under the Ministry of Health & Family Welfare (MOH&Fw)-Government of India. registered in January 1992 ( vide No. S-22590) under the Societies Registration Act 1860. laid down in Bye-Laws of  the institute.
    The  institute responsibly assures and reviews the quality of number of  Biological products available through domestic manufacturers or imports. The operations are carried out in the state of the art Facility of the Institute and in close coordination with Government of India regulatory authorities as Office of Drug Controller of India, Indian Pharmacopeia Commission.
    With the current science and technology leading to the development of newer biologicals in the domestic market,  the testing and specifications may vary for each specific products which  requires  an improved understanding of quality and  safety issues .In recent years the licensing and quality control for manufacturer  and  National Regulatory Authorities alike has become even more complex. With this overall objective and to strengthen regulations of  biologicals in India , NIB which supported by the authorities  constituted of   Governing body and General Body of the Institute plays a vital role.
Sample Receipt & Report Dispatch Unit Sera Panels National Reference Standards

Sample Receipt and Report Dispatch Unit (SRRDU) procedure

  • SRRDU  has been set up as independent unit in 2008.   The sample receipt unit being the main entry point of all samples to the Institute for testing, this unit has been accredited by NABL for elaborate documentation procedures. The Standard Operating Procedures (SOPs) have been amended to regulate Sample receipt to make the system flexible.
  • Quality evaluation 

    • The Institute has undertaken systematic evaluation of biological products as per Pharmacopoeia /WHO requirement for 1516 batches during the year 2012-13  as compared to 1093 batches tested in the year 2011-12.
  • Sample Receipt and forwarding

      • Receipt of samples from the Drug Controller General of India  /Authority    Verification of   supporting documents, quantity,   shelf life, fees for testing  samples
      • Rejection of samples
      • Coding of samples
      • Sample forwarding to designated labs
      • Receipt of coded samples in product testing laboratories
  • Generation of Test Analysis Report

  • Testing of coded samples
  •  Decoding of samples after testing  critical parameters
  • Receiving Documents for  Scrutiny of Manufacturing and QC  protocols
  •  Final test report preparation
  • Tracking of Samples  for its Turn Around Time (TAT)
  •  
  • Generation of Certificate of Analysis (CoA)

  • CoA generation by the Product testing laboratory
  •   CoA prepared by the Analyst and Approved by the Laboratory  Head
  •   Authorization of the Test Report 
  • Dispatch of Certificate of Analysis (CoA)

  • Release of the Certificate of Analysis with a covering letter  by the SRRD  unit Incharge to the sample sender  
  •   Dispatch of Report by the SRRD unit
  •   Tracking of sample Report status by the  Manufacturer /  Importer/   Authorities
  • Record Management (Archiving)

  • The files have been classified and kept in a sequential manner and is easily 
  • traceable. All records are under the custody of Oi/c SRRD Unit to which the Archive unit is attached.

Complaints

    1. Complaints, if any, are treated as confidential and given due consideration unless otherwise desired by the Government or by law.Complaints can be through any means of communication e.g. letters, e-mails, fax, and telephones (to be followed by written complaint).
    1. All stored samples received for quality testing at NIB are finally destroyed as per standard operating procedures of discarding stored samples.

 

Type of Biologicals products tested : 

Diagnostic Kits   HIV/HBsAg/HCV (Rapid & ELISA Confirmatory   Combo kits
Blood Products Albumin, Normal & Specific Human    Immunoglobulin (IM/IV)  Plasma Protein Fraction, Factor VIII, Factor IX and Sealant kits.
 Recombinant Products  rh. Insulin & insulin analogues (vials, Prefilled syringes & Cartridges), Exenatide, rh. Erythropoietin, Interferon and rh. GCSF (Granulocyte Colony Stimulating Factor)  
Blood Reagents Anti-A/B/AB, Anti-D (IgG)(IgM), Anti-D-(IgG+IgM), Blood Grouping Kits (Cards for Reverse & Forward grouping)
Enzyme &  Hormones Streptokinase, Menotropin, Human Chorionic  Gonadotropin (hCG), Follicle Stimulating  Hormone (FSH normal & Recombinant), Heparin  
Biochemical Kits Glucose Reagent & Blood Glucose Test Strips

Documents required for the sample submission.

  1.   Copy of import license ( imported samples)
  2.   Certificate of Analysis from the manufacturer/NCL
  3.   Batch release certificate from NCL/NCA
  4.   Name of three countries where the product is being marketed
  5.   Certificate to the effect that the product has not been withdrawn from the market of the 
  6.        country of origin and  exporting countries
  7.    Manufacturing and QC protocols of the product.

 

 

Quantity Required

 

 
REVISED RATES OF TESTING CHARGES / FEE APPROVED AND APPLICABLE W.E.F. 01.06.2016

Acceptance Criteria for Test & Examination of Blood Glucose Test Strips as per ISO 15197:2013

 

Turnaround time for testing 

PROPOSED FOR COMMENTS :

 

 

   

 

 

 

 

  Guidance Documents on Laboratories Tab 

 



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